FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
02/12/1992
Recalls and Field Corrections: February 12, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
Product: Sea Wave brand Frozen Whole Anchovies, harvested 9/91
through 11/91. Recall #F-072-2.
Code: All anchovies harvested during the months of September
1991 through November 1991. Specific lot numbers are as
follows:
101217 packed in cases of 33-1 pound boxes and cases of
25 pound bulk, harvested 10/12/91;
15/17 count packed in cases of 25 pound bulk, harvested
11/2-4/91;
9-6-18 harvested 9/6/91; 9-6-18H harvested 9/6/91;
9-26-28 harvested 9/25/91; 10-2-17 harvested 10/2/91;
17/18 harvested 10/12-13/91; 101523 harvested 10/15/91;
11116 harvested 11/1/91; 17/18 harvested 11/6-10/91;
17/18 harvested on 11/10-11/91; 111617 harvested
11/16/91 and 11/18/91.
-1-
Manufacturer: Monterey Fish Company, Inc., Sand City, California.
Recalled by: Manufacturer, by letter and by telephone November 19 and 27,
1991. Firm-initiated recall ongoing.
Distribution: Utah, Colorado, Washington state, California, Belgium.
Quantity: 5,642 (1 25-pound box per case), 757 cases (33 1-pound
boxes per case), 158 cases (1 55-pound bulk IQF per case),
105 cases (45 1-pound plastic bags per case) were
distributed.
Reason: Contaminated with domoic acid in excess of 20 parts
per million.
----
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: (a) Dolly Madison bakery Zingers; (b) Dolly Madison
Bakery Cup Cakes. Recall #F-088/089-2.
Code: (a) G19-AUG 26, G20-AUG 27, G22-AUG 29, G23-AUG 30,
G24-AUG 31, G26-SEP 02, G27-SEP 03, G29-SEP 05, G30 SEP 06,
G31-SEP 07; (b) H19-AUG 26, H20-AUG 27, H22-AUG 29,
H23-AUG 30, H24-AUG 31, H26-SEP 02, H27-SEP 03, H29-SEP 05,
H30-SEP 06, H31-SEP 07.
Manufacturer: Interstate Brands Corporation, Columbus, Georgia.
Recalled by: Interstate Brands Corporation, Kansas City, Missouri,
by telephone. Firm-initiated recall complete.
Distribution: Georgia, South Carolina, Alabama, Mississippi, Florida,
North Carolina, Tennessee, Maryland, Virginia, Louisiana.
Quantity: (a) 105,012 packages; (b) 27,324 packages were distributed.
Reason: Product is contaminated with mold.
----
Product: CX brand Black Tigers Frozen Shrimp packed in clear plastic
bag inside a green and white cardboard box, 26/30 count.
Recall #F-115-2.
Code: None.
Manufacturer: Far East Cold Storage Company, Ltd., Samutprakarn, Thailand.
Recalled by: Star Market Company, Cambridge, Massachusetts, by
internal memorandum January 1, 1992. Firm-initiated
recall ongoing.
Distribution: Massachusetts.
-2-
Quantity: 981 cases were distributed.
Reason: Product is decomposed.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Recovered Plasma. Recall #B-054-2.
Code: Unit #22932.
Manufacturer: LaGuardia Hospital, Forest Hills, New York.
Recalled by: Manufacturer, by letter August 20, 1991. Firm-initiated
recall ongoing.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood product, which tested initially reactive for
hepatitis B surface antigen (HBsAg), was distributed.
----
Class III -
Product: (a) Digestol brand Simethicone packed in 60 tablet bottles
with the following labeled ingredients: pepsin, bile salts,
dehydrocholic acid, amylolytic enzyme, lipolytic enzyme and
simethicone;
(b) Digestol brand Elixir, in 6 fluid ounce bottles with
the following ingredients: pepsin, lactic acid, alcohol.
Recall #D-210/211-2.
Code: All lots.
Manufacturer: Lex, Inc., Miami, Florida.
Recalled by: Kramer Labs, Inc., Miami, Florida, by letter September
18, 1991. Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: Approximately (a) 2,731 bottles; (b) 572 bottles were
distributed.
Reason: Product contains pepsin and dehydrocholic acid,
ingredients not permitted by Regulation 310.545.
----
-3-
DEVICES AND RADIOLOGICAL PRODUCTS
Mandatory Recall -
Product: Sporicidin Cold Sterilizing Solution;
(b) Sporicidin-HD Disinfecting Solution, for dialysis
machines and hemodialyzers. Recall #Z-225/226-2.
Code: All lots.
Manufacturer: Chem-Mix, Inc., Jonesborough, Tennessee (contract
manufacturer).
Recalled by: Sporicidin International, also known as The Sporicidin
Company, Rockville, Maryland, by letter December 18,
1991. FDA-ordered recall ongoing.
Distribution: Nationwide and international.
Quantity: 23,000 units were distributed.
Reason: Mandatory 518(e) recall. The devices when used as directed
on the label are not effective sterilants and are not
effective as high level disinfectants.
----
Class I -
NONE
Class II -
Product: Oxygenator, product #396049. Recall #Z-135-2.
Code: Lot numbers: 15159, 15183, 15131, 15265.
Manufacturer: Original Equipment Manufacturing Medical, Inc., (OEM),
Division General Medical Manufacturing, Richmond, Virginia.
Recalled by: Manufacturer, by telephone and by letter on or about
December 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 11,000 units were distributed.
Reason: The blue corrugated exhalation tube was obstructed with
a white plastic plug or disc.
----
Product: Model 780-I-VFA15 Laser Machining System. Recall #Z-267-2.
Code: Serial #063.
Manufacturer: Lumonics Corporation, Eden Prairie, Minnesota.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan December 30, 1991. Firm-initiated field correction
complete.
Distribution: Washington state.
Quantity: 1 unit.
Reason: Noncompliance with performance standard for laser
products in that it was not correctly classified as a Class
II laser product; and it had either inadequate or missing
interlocks.
----
-4-
Product: Laser Diode Modules: (a) Model 5mw VLM; (b) Model VLM;
(c) Model VLM-1; (d) Model VLM-2; (e) Model VLM-2R;
(f) Model 1mw VLM. Recall #Z-269/274-2.
Code: None.
Manufacturer: Applied Laser Systems, Inc., Grants Pass Oregon.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan January 2, 1992. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 906 units were distributed.
Reason: Noncompliance with performance standard for laser
products in that they lacked emission indicators.
----
Product: DLP Coronary Artery Retraction Clips, used to temporarily
retract open the fatty surface layer of the myocardium
over the coronary artery to improve exposure of the vessel
during coronary anastomosis:
(a) Product Code #16115, 1.5 mm Clips;
(b) Product Code #16130, 3.0 mm Clips;
(c) Product Code 16150, 5.0 mm Clips. Recall #Z-278/280-2.
Code: Lot numbers: 6901-0001, 6890-9001, 6900-2001, 6900-3001,
6900-6001, 6900-5001, 6900-3002.
Manufacturer: Pioneering Technologies, Inc., Wheat Ridge, Colorado.
Recalled by: Manufacturer, by telephone and by letter December 16,
1991 to subdistributors, and subrecalled by DLP Inc.,
Grand Rapids, Michigan, January 1, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 565 boxes (10 clips per box) and 850 individual sample
clips were distributed.
Reason: The sterility of these devices may be compromised because
the clip prongs were puncturing the packaging as well as
shredding of the packaging material upon opening.
----
Product: Synerview Computed Tomography X-Ray Systems:
(a) Model 600SE; (b) Model 600SX; (c) Model 1200SX.
Recall #Z-287/289-2.
Code: All units.
Manufacturer: Picker International, Cleveland, Ohio.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan January 16, 1992. Firm-initiated field correction
ongoing.
Distribution: Nationwide and international.
Quantity: 1,025 units were distributed.
-5-
Reason: Noncompliance with the performance standard for x-ray
products in that design specifications relating to the
emission of electronic product radiation was not confirmed.
----
Product: Continuum Knee System (CKS) Tibial Inserts:
(a) CKS Tibial Insert #2/8.5 mm, Part #805-6402;
(b) CKS Tibial Insert #10/8.5 mm, Part #805-6410;
(c) CKS Tibial Insert #2/11.5 mm, Part #805-6412;
(d) CKS Tibial Insert #6/22 mm, Part #805-6446.
Recall #Z-290/293-2.
Code: Lot numbers: (a) 18531; (b) 18919, 19467;
(c) 18533, 19447, 19707; (d) 18913.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer, by letter on December 10, 1991.
Firm-initiated recall ongoing.
Distribution: Arizona, Colorado, California, Connecticut, Illinois,
Indiana, Minnesota, North Carolina, Ohio, Oregon,
Tennessee, Texas, Virginia, Wyoming.
Quantity: 57 units were distributed.
Reason: The inner patient/reorder labeling included with the
product incorrectly identifies the insert thickness.
The outer package labeling is correct.
----
Product: Externally Assembled Lower Limb Prostheses, AKA,
Above knee prostheses appliance/artificial leg.
This is a custom device that is labeled: Harry J. Lawall
& Son, Philadelphia, Pennsylvania. Recall #Z-295-2.
Code: Lot numbers are not used for this custom device.
Manufacturer: Teh Lin, Taiwan.
Recalled by: Harry J. Lawall & Sons, Inc., Philadelphia, Pennsylvania,
by letters of December 30, 1991. Firm-initiated recall
ongoing.
Distribution: Pennsylvania, New Jersey, Delaware.
Quantity: Firm estimates 10 to 25 units are in use.
Reason: The Teh Lin above the knee wood block, TWB-4 series
component appeared to be fracturing while in use and
may cause a severe malalignment of the leg components.
Reason: Noncompliance with the performance standard for laser
products in that the purchasers were not provided
a procedure and schedule for calibration of the
measurement system.
----
Product: AMK Total Knee System Femoral Revision Components:
(a) Product #1488-11, Small Size Right Knee Component;
(b) Product #1488-12, Small Size Left Knee Component;
(c) Product #1488-13, Large Size Right Knee Component;
(d) Product #1488-14, Large Size Left Knee Component.
Recall #Z-298/301-2.
-6-
Code: Lot numbers: (a) 536620, 564956, 570240, 570250, 570260,
570270, 633940, 716970, 925920;
(b) 570290, 570300, 714836, 853400, 853410;
(c) 537256, 570320, 570330, 570340, 570350, 524206, 524207,
654316, 654317, 716206, 818530, 404726;
(d) 537090, 570390, 570400, 570410, 570420, 570430, 586850,
638380, 717006, 818540.
Manufacturer: DePuy Division, Boehringer Mannheim Corporation,
Warsaw, Indiana.
Recalled by: Manufacturer, by letter November 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Australia, Japan, Canada, France, Taiwan, Korea,
Mexico, Finland, England.
Quantity: 191 units were distributed.
Reason: The femoral component will not articulate properly with
the tibial insert component.
----
Product: Eldorado Series Cobalt 60 Teletherapy Units:
(a) Eldorado G; (b) Eldorado Super G;
(c) Eldorado 6; (d) Eldorado 8; (e) Eldorado 76;
(f) Eldorado 78. Recall #Z-302/307-2.
Code: Serial numbers: E6 008, E6 013, E6 018, E6 024, E6 028,
E6 038, E6 053, E6 011, E6 016, E6 019, E6 025,
E6 036, E6 039, E6-055, E6 065, E6 080, E6 067, E6 097;
E76 003, E76 005, E76 1X;
E78 002, E78 003, E78 008, E78 010, E78 013, E78 027,
E78 028, E78 050, E78 051, E78 058, E78 061, E78 063,
E78 064, E78 902, E78 903;
E8 005, E8 006, E8 007, E8 018, E8 019, E8 021, E8 024,
E8 026, E8 028, E8 029, E8 030, E8 033, E8 037, E8 038,
E8 042, E8 050, E8 052, E8 057, E8 061, E8 064, E8 065,
E8 071, E8 074, E8 101, E8 102;
EG 017, EG 021, EG 024, EG 026, EG 027, SG.
Manufacturer: Theratronics International Limited, Carrollton, Texas
(importer).
Recalled by: Theratronics International Limited, Kanata, Ontario,
Canada, by visit beginning December 10, 1991. Firm-initiated
field correction ongoing.
Distribution: Maryland, Texas, New York, Kansas, California, Florida,
Missouri, Delaware, New Hampshire, Illinois, Pennsylvania,
Louisiana, Colorado, Wisconsin, New Mexico, Arizona, Wyoming,
Tennessee, Alabama, Minnesota, New Jersey.
Quantity: 67 units.
Reason: Separation of the two halves of the coupling that
connects the reducer to the ball screw can result in
the treatment head falling suddenly.
----
Class III -
-7-
Product: Versa-Fx Lag Screw Inserter, Product #1199-001, a surgical
instrument used to insert a lag screw into the femur head
during fracture fixation procedures. Recall #Z-297-2.
Code: Lot #78915400.
Manufacturer: Tuco Instruments, North Attleboro, Massachusetts.
Recalled by: Zimmer, Inc., Warsaw, Indiana, by letter December 10, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 40 units were distributed.
Reason: Lag Screw Inserter may not slide properly inside the "Tube
and Plate" bone plate device.
----
Product: COMPAT Conductivity Standard Solution, Catalog #7050,
in 32 ounce plastic bottles, an in-vitro diagnostic, used
to standardize conductivity meters that are used as an
accessory to a hemodialysis system. Recall #Z-308-2.
Code: 9501 SEP. 92.
Manufacturer: Alden Scientific, Inc., West Springfield, Massachusetts.
Recalled by: Alden Scientific, Inc., Winthrop, Massachusetts, by
telephone October 4, 1991. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 6 bottles were distributed.
Reason: The Device contained sodium chloride instead of potassium
chloride as stated on the label.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Ken-L Ration Original with real Beef & Chicken Dog &
Puppy Food, in 14 ounce cans. Recall #V-015-2.
Code: Case code: 09300 11/01/91 V S7 6;
Can codes: 1V01K/K06 05:00 through 1V01K/K06 05:59.
Manufacturer: The Quaker Oats Company, Topeka, Kansas.
Recalled by: The Quaker Oats Company, Chicago, Illinois, by
telephone January 9-10, 1992, and by letter dated
January 16, 1992. Firm-initiated recall ongoing.
Distribution: Tennessee, Iowa, South Carolina, North Carolina,
Wisconsin, South Dakota, North Dakota, Minnesota,
Iowa, Michigan.
Quantity: 1,485 cases (24 cans per case) were distributed; firm
estimates 75 percent remains on the market.
Reason: Product contains metal fragments.
----
Class III -
NONE
-8-
Class III -
NONE
Medical Device Safety Alerts:
Product: Disposable Defibrillation Cables, used with various
LIFEPAK models. THe cables are used in 1 of 4 different
product configurations depending on the model:
(a) Cable is hardwired into the units (i.e. fixed part of
the product). Models LP 200 and LP 250, both of which
are semi-automatic in operation;
(b) Cable is hardwired to an adapter, which is placed into
the standard external paddle wells and the standard paddles
placed into the adapter. This is an optional accessory for
models LP 5, LP7 and LP10;
(c) Cable is detachable and is connected directly to the
unit. LP6s and LP 300;
(d) Cable is detachable and is connected to an adapter,
which is placed into the standard external paddle wells.
The adapter and cable are optional accessories for models
LP 8, LP 9, LP 9A, LP 9B, and LP 9 SAS.
Safety Alert #M-033-2.
Code: All lots.
Manufacturer: Physio-Control Corporation, Redmond, Washington.
Alerted by: Manufacturer, by letter November 22, 1991.
Distribution: Nationwide and international.
Quantity: Approximately 10,000 cables/adapters were distributed.
Reason: The cables were failing to function during use, due to
damage or being worn out, and not being tested as part
of the standard defibrillator tests.
----
Prosecution Actions Filed:
Against: John Emmanuel Botzolakis, former Senior Scientist for
Parke-Davis Company, Morris Plains, New Jersey.
Product: Erythromycin and Prazepam formulas and manufacturing
processes.
Charge: Stolen confidential commercial information regarding the
formulas and manufacturing processes for Erythromycin and
Prazepam were transported from New Jersey to New York and
given to an official of another generic drug firm in
exchange for $14,000.
Filed: October 24, 1991 - U.S. District Court for the District of
Maryland, Statement of Facts, Criminal #HAR-91-0328.
Plea Agreement: Mr. Botzolakis pleaded guilty to conspiring to transport
confidential drug formula information in interstate commerce.
----
-9-
Seizure Actions Filed:
Product: Sensor Pad, a round latex rubber bladder containing silicone
which is sold for use as an aid in performing breast
self-examination (92-673-358).
Charge: Adulterated - The sensor pad is a class III medical device
which does not have in effect the required approved
premarket application.
Firm: Inventive Products, Inc., Decatur, Illinois; and Our Lady
of Lourdes Hospital, Binghamton, New York.
Filed: January 10, 1992 - U.S. District Court for the Northern
District of New York; Civil #92-CV-043 (NDNY), FDC #66338.
Seized: January 17, 1992 - 84 cases of sensor pads valued at $31,000.
----
Product: Miscellaneous hair growth products (91-617-062).
Charge: Products are unapproved new drugs; Misbranded - The
products' labeling lacks adequate directions for their
safe and effective use and the articles were manufactured
in an establishment not duly registered as required by
regulation.
Firm: American Beauty Products, Tulsa, Oklahoma.
Filed: January 22, 1992 - U.S. District Court for the Northern
District of Oklahoma; Civil #92-C-50-E, FDC #66283.
Seized: January 23, 1992 - goods and printed materials valued
at approximately $20,000.
----
Disposition of Prosecution Action:
Defendant: Alfred G. Maroun, and Maroun Brothers, Inc.,
Lawrence, Massachusetts.
Product: Flour (89-568-124).
Charge: On February 12, 1990, an indictment was returned
charging both Mr. Maroun and the corporation with
eight felony counts of adulterating food products in that
they consisted in whole or in part of a filthy substance,
and that they had been held under insanitary conditions
whereby they may have become contaminated with filth. In
addition, Mr. Maroun and the corporation have twice before
been convicted of similar charges -- operating a dirty
warehouse. The first violation was a misdemeanor conviction
and the second violation was a felony conviction.
Disposition: On October 27, 1991, Mr. Maroun plead the corporation guilty
to the eight counts charged in the indictment, and plead
himself guilty to three of the charged counts. On February
5, 1992, sentencing occurred for both the Food, Drug, and
Cosmetic Act charges and for Internal Revenue Service
charges. Because the corporation is bankrupt, no fine was
imposed on the corporation. Mr. Maroun was fined $5,000 and
sentenced to three years of probation and 2,000 hours of
-10-
public service with the provision that violation of the
Food, Drug, and Cosmetic Act would be a violation of his
probation. U.S. District Court for the District of
Massachusetts - FDA charges (CR #90-10027-T), IRS charges
(CR #89-211T); FDC #65707.
----
Defendant: Dr. George T. Zahorian, III, Harrisburg, Pennsylvania.
Product: Anabolic steroids.
Charge: On June 27, 1991, Dr. George T. Zahorian, III, was
convicted by a jury in Harrisburg, Pennsylvania, of four
counts of distributing anabolic steroids to a body
builder who was working as an undercover informant in
1989, four counts of distributing large quantities of
Schedule III and IV controlled substances to the same
informant, four counts of distributing anabolic steroids
to four different professional wrestlers between November
1988 and March 1990, and two counts of using his office
condominium complex to facilitate the distribution of
steroids and controlled substances. In addition, the jury
found that Zahorian's office-condominium, valued at
approximately $1.7 million, is subject to forfeiture to
the United States.
Disposition: On December 27, 1991, Dr. Zahorian was sentenced and
a fine of $12,700 was imposed. On each of the 12 counts
of conviction for distributing anabolic steroids and
controlled substances, Zahorian was sentenced to 36 months
imprisonment followed by two years of supervised
release. The sentencing will run concurrently. U.S.
District Court for the Western District of Pennsylvania.
-11-